Cicada Health Tech Hub
"Ask an Expert"

Connect with Brandon Capital

Brandon Capital is Australia’s leading life sciences VC, manages over $1 billion and has an active portfolio of more than 30 companies in therapeutics, devices, diagnostics, and digital health sectors.

Connect with Brandon Capital’s investment team to gain invaluable perspectives on what life sciences VCs look for in investment opportunities, receive feedback on commercialisation strategy, development plans, and commercialisation grant opportunities such as CUREator plus.

Additionally, if you are a researcher or clinician at the Westmead Health Precinct and would like to discuss your project in detail, please contact us to organise a 1:1 meeting with a brief description of your project, your affiliation(s), and contact details of the commercialisation manager/tech transfer manager at your organisation.

Prashanth Rajan, Analyst
Brandon Capital

Prashanth will offer you invaluable perspectives on the investment process and how to tailor your approach to meet investor expectations. He will help you learn about what life sciences VCs look for in opportunities, receive feedback on commercialisation strategy, development plans, and commercialisation grant opportunities such as CUREator plus

Brandon BioCatalyst, Australia’s leading life sciences VC, manages over $800 million and actively supports more than 30 companies in therapeutics, devices, diagnostics, and digital health sectors.

Availability:
In-Person at the Cicada HealthTech Hub -
Every Thursday morning | 30 minute sessions

Sean Harris, Director
Prime Financial Group 

Sean has worked in R&D tax for over 10 years, with a technical background in Biotechnology from QUT. The Prime Financial Group specialises in assisting life science companies with an integrated service offering, with a track record of working with hundreds of life science companies undertaking a broad range of clinical research activities in Australia and globally. Prime can help you with:

• ESIC (Early-Stage Innovation Company) advice, structuring of the company
• Virtual CFO
• Accessing the R&D Tax Incentive & Loans
• Annual financial and tax compliance & Capital Raising
• Employee Share Scheme advice

Jonathan Nambier, Consultant

Jonathan Nambiar is dedicated to helping clients communicate their technology value proposition to market participants. He has experience writing business plans and pitch decks for both public and private companies to support investment activities. Jonathan brings startup, management and board experience as the director of operations at channel bio / AbCellera Australia, the Australian subsidiary of AbCellera, a NASDAQ-listed biotechnology company. He also offers relevant industry experience from business development consulting (Bio-Link Australia, Tadpole Bio), healthcare equities investment (BML, Magellan) and therapeutic antibody drug development (AbCellera, Teva, Cephalon). Jonathan earned a doctorate in experimental medicine from the University of Sydney and an MBA from the University of Newcastle.

Consultant service offering:

• Strategic advisory, such as support for technical, IP, competitive landscape, market analyses, data room audit
• Coordinating documentation for the R&D tax incentive (working with an accounting firm to file)
• Executive coaching around start-up / scale-up activities
• Financial modelling and valuation (e.g risk-adjusted NPV; value-sharing ratios) to support capital
• Raisings and/or IP-related transactions
• Network of Wall St analysts, investors and biopharma executives

Daniel Ronai, Managing Director
Ronai Services Pty Ltd

Daniel BBus, GradDip FinApp, a registered R&D Tax Agent, has been helping clients receive the Research and Development Tax Incentives (R&DTI) and Export Market Development Grants (EMDG) since 2015. Focusing on start-ups and small businesses, his many clients receive between tens to hundreds of thousands of dollars through the R&DTI and EMDG (and sometimes millions through the R&DTI). He has 17 years previous experience in finance and compliance working for well-known companies including Computershare, Macquarie Bank, JBWere, Hillross, St George Bank and AMP. Daniel is currently Secretary of the R&D Tax Advisers Association Inc.

Daniel can help you with:

• Giving value to Founders by helping them with wider business issues.

• Being able to explain R&DTI in clear language while taking out the jargon and relating it to individual’s circumstances.
• Helping companies receive up to 48.5% back on their eligible R&D expenditure.
• Assisting with Advance Overseas Findings to allow companies to include overseas R&D activities in their R&D claims.

Brendan Brown, Principal
Prime Financial Group

Brendan is a Chartered Accountant and Registered Tax Agent. With over the past 20 years at Prime, he has worked closely with hundreds of life science companies and has also built strong relationships with the Venture Capital and Contract Research Organisation communities, and was involved with successful companies such as Spinifex Pharmaceuticals, Fibrotech and Hatchtech, where he acted as Company Secretary, CFO and R&D tax advisor.

Megan O'Conor, Managing Director
Kantara Consulting  

Megan O’Connor, PhD, MBA, leads Kantara Consulting with a deep commitment to her clients' success. Formerly the National Life Science Leader for Government Funding at Deloitte, Megan also brings experience in an emerging ASX-listed Australian biotech and academic research, having completed her PhD in Neurobiology. She bridges the worlds of science, business, and government to ensure Kantara Consulting delivers strategic, high-impact results.

Kantara’s core services for early-stage life science companies include:

• Comprehensive Grant Strategy & Management: Full-service grant writing, development, and submission support.
• Guided Grant Preparation & Review: A structured program with two annual intakes, providing expert guidance for competitive applications.
• Strategic Communications: Crafting clear, compelling messaging that resonates with stakeholders.
• Thought Leadership & Content Development: Establishing credibility and positioning companies as industry leaders.

Bruce Murray, R&D Tax Consultant
FundFindrs 

FundFindrs helps businesses secure funding through grants, traineeships, and awards. Offering a 'no win, no fee' approach on key grants like the R&D Tax Incentive. Bruce has previous experience at Department of Industry, Science and Resources (DISR) / AusIndustry within the R&DTI program, managing and accessing R&D Tax Incentive applications in line with legislative requirements. Specialising in these applications, Bruce has assisted R&DTI applicants assessing eligible R&D activities and related expenditure.

Bruce and the team at FundFindrs can help you in the areas of:

• R&D Tax incentive
• Grants
• Awards
• Traineeships

Colin Denver 
Principal Consultant, Dennova Consulting 

Colin Denver is a dynamic and results-oriented leader with a strong entrepreneurial background and a proven track record of establishing and driving sustainable growth within organisations. Notably, as the former CEO of SpeeDx, he spearheaded the company's successful entry into the infectious diseases diagnostic market. During his tenure, he strategically led the development and commercialsation of over 15 new regulated molecular diagnostic products. Furthermore, Colin was instrumental in securing significant strategic partnerships with major diagnostics companies such as Labcorp and Cepheid, which were pivotal in expanding the company's global reach and impact. In previous roles at Meridian Bioscience and Bioline, Colin led regional offices and built high-performing teams across Asia-Pacific, successfully growing market share and establishing the groundwork for new product launches in multiple global markets.

What Colin can help you with:

• Fundraising and guidance for securing capital
• Commercial launch planning
• Market assessment and development
• Strategy and partnerships

Dr Kerstin Schϋtz
Director, StrandnBerg Pty Ltd 

Kerstin is a highly accomplished executive and non-executive Director, recognised for her strategic leadership and ability to drive innovation translation. Kerstin has worked globally in Europe, the US and Australia in leadership roles with global pharmaceutical companies and Australian biotech companies. She works as an adviser for government commercialisation grants and has extensive knowledge in IP licensing and commercialisation having worked in the University tech transfer sector. She is experienced in working at the interface between research organisations, government programs and industry.

Kerstin can help you with:

• Commercialisation advice focused on Medtech and Biotech
• Business strategy
• Governance
• Grant funding advice
• Strategic advice on drug development and manufacturing strategy and partnering
• IP Strategy including licensing and assignment of IP

Dr Robert Feldman, Member
LifeScience Australia New Zealand

Robert brings deep, broad, and international expertise across therapeutics, medical devices, and in-vitro diagnostics. With a foundation in medicine, academia, venture capital, and EIR roles—and having founded/led six biotech companies—he offer hands-on, holistic support to startups and early-stage ventures navigating complex growth paths. Robert has consistently operated at the front lines: launching companies, raising capital, securing IP, leading R&D teams, negotiating licensing deals, shaping strategy, resolving operational challenges, and serving on boards, with experience spanning a diversity of domains, with a particular interest in infection and immunology.

Areas of support include:

• Company formation and structural design
• Budgeting and financial planning
• Investment readiness and fundraising strategy
• Business development and partnerships
• Strategic planning and realignment

Jennifer Wilson
Principal, LeanForward 

Jennifer Wilson is an executive leader with over 30 years' experience in the global online, mobile, and digital sectors. She has held CEO and director-level roles, built startups, and successfully commercialised new ideas. She also brings deep board-level experience, having served as a Non-Executive Director and Chair in both the UK and Australia. Jennifer is a commercially focused and well-connected leader with strengths in finance, marketing, and business development — especially across content, entertainment, and health and well-being. Known for her values-driven leadership style, she brings strategic clarity, integrity, and an inclusive lens to every role she undertakes.

Jennifer can help you with:

• Governance and risk management, organisational structures, and strategic partnerships
• Commercialisation strategies, business models, pricing structures, and go-to-market channels
• User-focused design, with an emphasis on gamification to enhance engagement and drive behaviour change

Kirsten Karbowiak, founder
BDM by the hour 

Kirsten is a seasoned mentor and founder of BDM by the hour, passionate in supporting new business owners and start-up companies by offering quality sales support and investing in relationships for long-term growth across all portfolios. Whether that be providing Sales Mentoring for new business owners, or Sales Management for growing ones Kirsten and her team can provide practical, tactical and relevant advice on direction and accountability in the sales space.

Kirsten can help you in:

• Identifying and building your first partnerships
• How to network effectively face to face
• Building a sustainable pipeline
• Using the phone and selling confidently

Bhavin Raval
Experienced CFO with startup & scaleup companies 

Bhavin is a seasoned CFO with over 20 years of experience in the biotech and startup sectors across the USA and Australia. Known for driving strategic decision-making and facilitating business transformation, Bhavin has played a pivotal role in senior leadership teams, including the noteworthy acquisition of Calimmune Inc. by CSL for a milestone based consideration of USD 416 m. Bhavin excels in guiding startups through critical phases of development and empowering startups to achieve immediate financial targets and establish a framework for long-term success.

What Bhavin can help you with:

• Financial strategy and capital management
• Operational excellence during startup to scaleup journey
• Strategic planning, growth, exits
• Risk management and mitigation
• Investor relations and corporate governance

Katherine Robinson, Global CEO,
Miroma Project Factory 

Katherine Robinson is an experienced digital strategist and Global CEO of Miroma Project Factory, where she leads innovation strategy across health, government, and enterprise sectors. With a focus on digital commercialisation and partnership development, Kat helps early-stage health tech ventures bridge the gap between promising ideas and scalable, fundable digital solutions.

She’s known for building smart delivery roadmaps, forming impactful partnerships, and guiding spinouts through funding, procurement, and adoption pathways.

Katherine can help you with:

• Commercialisation strategy for emerging bio/med/health tech
• Navigating grant programs, R&D incentives, and early-stage funding opportunities
• Scaling MVPs into long-term sustainable digital services
• Strategic partnerships and procurement navigation
• Building strong cross-functional teams for delivery and growth

Neil Deacon, Managing Director
Health Advance Connect 

Neil has over 14 years of global experience in strategy consulting across the health and life sciences ecosystem. He has worked with a diverse range of organisations, including major pharmaceutical companies, biotech firms, medical device companies, life science start-ups, academic consortia, government health departments, hospitals, and primary health networks.

Through Health Advance Connect, Neil supports early-stage companies with business and operational strategies, strategic execution, and navigating the complexities of the health and life sciences landscape.

Neil can help you with:

• Supporting the development and articulation of successful business strategies.
• Navigating the health and life sciences ecosystem by identifying customers, payers, and partners for your business.
• Advising on strategies for engaging stakeholders effectively.
• Building Target Operating Models / Business Models

Ilma Rahmathullah, Director
Independent (ex-Catholic Healthcare)  

Ilma Rahmathullah is an award-winning innovation leader with 15+ years translating frontier tech into safe, adoptable care. At Catholic Healthcare, she architected and operationalised a XR enabled virtual care model across 41 residential facilities, unlocking >$300K in funding and measurable wins in wound care, avoided hospital transfers, and improved staff job satisfaction. Ilma blends systems thinking (Lean), co-design with clinicians and families, and compliance-first delivery to de-risk adoption in complex settings. A member of ARIIA’s Innovation Validation Panel and winner of the ITAC Excellence in Technology Implementation award, she partners with founders, providers, and key stakeholders to move from evidence to everyday practice—fast—through right-sized pilots, operating playbooks, and clear go-to-market strategies.

She can help you with:

• Turning ideas into market-ready solution and building scalable operationalisation plans
• Guidance in human-centred design and clinical integration, mapping journeys, develop personas and test usability and ensure tech adoption sticks with measurable ROI
• Advise on operations and change management to ensure sustainable workflows in complex care settings
• Advise on business cases and pitch towards investor-readiness

Adam Wardell, CEO, Principal Consultant
Previsior

With over 25 years of experience in health, Adam is the CEO at Previsior, a boutique life sciences consultancy specialising in strategy, innovation, and commercialisation for health technologies. Spanning pharmaceuticals, biotech and digital health products, Adam has a proven track record of bringing innovation to the market, guiding and mentoring startups and established companies through the complexities of launch and scale-up. Passionate about putting Australian innovation on the global stage, Adam and his team can provide comprehensive guidance tailored to your startup’s specific needs, specifically:

• Commercial Strategy
• Value Proposition Design
• Business Model Innovation
• Go-To-Market Modelling (& Voice-of-Customer)
• Business Development Strategy
• Pathways to Partnerships
• Becoming Investable (mapping value inflection)

Sarah Cummings, Managing Partner
Sarah Cummings Consultancy 

Sarah has over 25 years’ experience developing and delivering products and services across financial, health and education for both large and small companies. She specialises in supporting startups and scaleups to create effective communications and impactful pitches as well as designing and implementing practical operational governance programs.

Sarah can help you with:

• Communication strategy and collateral
• Pitch decks and presenting
• Defining and implementing operational governance frameworks and processes

Malav Trivedi, Executive Director
Pragnya Consulting pty ltd 

Malav is passionate about supporting founders as they transition from concept to commercialisation, ensuring their innovations align with market needs, investment readiness, and long-term growth strategies. With deep expertise across biotech, and healthcare they help startups navigate business priorities, R&D strategy, and resource efficiency to maximise impact. Malav is also actively involved in global expansion initiatives, helping Australian startups secure funding, scale internationally, and bridge scientific and commercial strategies.

Key support areas:

• Helping founders define business priorities, commercial validation roadmaps, and R&D strategies for regulatory and commercialisation success.
• Supporting product market fit for early traction and technical validation of innovations in diagnostics, therapeutics, SaMD and biotech-sustainability.
• Ensuring research efforts are structured for long-term IP / patent defensibility and market alignment.
• Assisting startups in navigating through recommended regulatory pathways, securing early funding, and scaling globally.
• Designing and leading sessions on biotech VC / accelerator engagement, pre-clinical and clinical trial acceleration, executive talent pipelines

Aaron Cheang, UX Research & Design Consultant
Personix

Design & user research experts at Personix can help you make more effective product decisions in successfully getting your product to your customers quickly. Aaron here can help start-ups like you by helping you:

• Define your product/project problem
• Identify your market segments
• Optimise methods to get rapid feedback on your product
• Ideate and create solutions to your product's problems
• Test your solution(s) to get meaningful feedback

Lynette Reeves, Digital Health Lead | Behavioural Insights Lead
Miroma Project Factory

Lynette Reeves is a digital health strategist and behaviour change specialist with over a decade of experience transforming complex bio, med, and health tech concepts into evidence-based, user-friendly digital tools. At Miroma Project Factory, she leads the health and innovation practice, delivering regulatory-conscious, scalable digital platforms across government, research, and health sectors. Her expertise lies in combining behavioural science with human-centred design to create tools that are engaging, ethically grounded, and ready for real-world use.

Lynette can help you with:

• Designing and validating digital health MVPs, including app and platform development
• Applying behavioural science to improve engagement, adherence, and outcomes
• Co-designing with clinicians, researchers, and lived experience groups
• Crafting ethical, accessible UX for data capture, consent, and longitudinal use
• Translating clinical and research insights into digital prototypes that users understand and trust

Theresa Lim, Head Coach (Play2Lead) + Head of Product (inTruth)
Play2Lead & inTruth

Theresa Lim is a 3x founder and executive coach with 30 years’ experience across startups, corporates, and scaleups in healthtech, AI, and product innovation. She has coached founders since 2018, helping them navigate uncertainty, build critical thinking skills, and lead diverse, high-performing teams. Currently Head of Product at inTruth, she’s building the world’s first Emotion Language Model (ELM) to support emotional intelligence at scale. As founder of multiple award-winning startup Play2Lead, a gamified behaviour change platform + coaching/consultancy, Theresa brings deep expertise in product-market fit, UX design, and early-stage ideation—helping founders translate user insights into scalable, compliant solutions. She is especially passionate about responsible AI and building products that create lasting human impact. Theresa can help you with:

• Balancing R&D with commercial nous and compliance as part of go-to-market.
• Tailoring value proposition to relevant parties (early adopters, investors, etc.)
• Identifying, prioritising, and mitigating risks (including iterating and testing new features)

Tara Sharma, Managing Director
Innov8Search 

Tara is the managing director of Innov8Search with an extensive career history in healthcare, life sciences and executive search and has an unparalleled network across the ANZ region. Innov8Search is ANZ's leading technical and executive search partner, supporting search and recruitment services in the medical device, biotechnology, pharmaceutical, life sciences space across ANZ.

Tara can help with connecting you with specialist C-Suite advisors and consultants in your space, including:

• CEO, CFO, COO, CTO's
• Medical Affairs Directors
• Marketing Directors

Carla Zampaglione
Managing Director, Sento

Carla leads Sento, a team of specialist human factors and usability engineers for medical devices and digital health products. Sento partners with bio/med/health tech founders anywhere from concept to clinical trials. We turn risky assumptions into evidence, proving your product is safe, building investor confidence, and regulator-ready usability documentation. Sento is known for fast, lean research sprints, pragmatic design guidance, and clear documentation that maps directly to ISO 62366-1, IEC 62366-1/HE75, and ISO 14971. Their work helps teams sharpen value propositions, accelerate proof points, and avoid expensive late-stage rework on the path to regulatory approval.

Carla can help you with:

• Usability risk & early hazard analysis: Map real-world workflow for your product, identify use-related hazards, and generate clear Design Inputs to inform your design and development.
• SaMD & AI product testing: Test your early-stage prototypes, then translate findings into clear user interface / labeling changes that improve safety, onboarding, and adherence.
• Regulatory-ready usability engineering file: Plan and assemble the usability engineering file that aligns with FDA, TGA, and EU MDR expectations.

Antonia Skitsas
Technical Director, Skiant Holdings Pty Ltd 

Skiant Holdings is an engineering and development consultancy with a strong track record of helping both medical and non-medical startups bring their ideas to life. The company supports clients from the early stages of ideation and product evaluation through to mechanical design, prototyping, and manufacturing. They specialise in solving complex technical challenges, including temperature control, acoustic issues, material selection, mechanical design, and cable design. Their comprehensive approach ensures that every product meets the necessary regulatory and quality standards required to succeed in complex markets.

They can help you with:

• Concept Validation & Product Feasibility
• Technical Problem Solving (i.e thermal management, acoustics, sterilisation)
• Rapid Prototyping & Manufacturing
• Mechanical Design
• Regulatory Compliance & Quality Management
• Product Development Strategy for Startups

Dr Andrew Knill, Formulation and Process Development Specialist
StrandnBerg Pty Ltd

Andrew is a seasoned pharmaceutical industry leader with a PhD in organic chemistry and +20 years having worked in the global pharma sector, including 17 years at Pfizer. His experience includes bringing molecules to market, having led cross-functional efforts in formulation, process development, impurity profiling and regulatory dossier submissions (globally). He is the author of numerous patents and experienced as an expert witness in patent infringement cases globally. His strength is in thinking beyond conventional frameworks while keeping commercial reality front of mind.

Andrew can help you with:

• Support drug development and formulations strategy, specifically in product development planning to ensure development of a scalable product with strong market fit and increase the valuation of your asset and minimise risk to investors.
• Therapeutics manufacturing planning and strategy
• Therapeutic formulation Regulatory dossier advice
• IP strategy
• Funding strategies to support capital raising and your commercialisation journey-practical 
  approaches
• Development of a commercialisation strategy and validation of your critical path to market, resulting in SMART goals.

Gordon Malouf, Med-Tech Venture Partner
Cicada Innovations 

With over two decades of experience in the medical device industry, Gordon has held key roles in Applied Research, Product Development, Technical Due Diligence, Product Marketing, Program Management, and Medical Affairs. His most recent venture as a co-founder of an in-house medical device startup has successfully scaled up across five countries with hundreds of units sold into the United States, securing reimbursement from both the Federal Government and major private insurers.

Gordon can help provide advice for your medical device journey on:

• R&D
• Product Development
• Clinical Validation
• Evidence Generation Strategy
• Medical Affairs

Dorrin Asefi, Systems Lead
Enovis

Dorrin Asefi is a product development strategist who helps MedTech startups accelerate development while maintaining regulatory compliance. She specialises in setting up lean, optimised systems and strategic frameworks that support fast-paced R&D with regulatory clarity.

With hands-on experience across R&D, regulatory affairs, and quality systems, Dorrin has built QMS from scratch, led mechanical and software V&V programs, and designed in vivo/in vitro studies to demonstrate safety and efficacy. She works with both startups and corporate teams to align development with investment priorities, consolidate efforts, and drive scalable, audit-ready execution. 

She can help with;

• Development and execution of product development strategies
• Setting up smart, scalable QMS and technical documentation (ISO 13485, GLP, 21 CFR 820/11)
• Planning and execution of mechanical/software V&V and in vivo/in vitro preclinical studies
• Navigation of regulatory pathways (TGA, FDA, MDR)
• Risk management, early manufacturing engagement, and streamlining fragmented workstreams into audit-ready systems

Dieter Hamprecht, Head of Chemistry,
Syntara

Dieter Hamprecht has extensive experience in drug discovery and the development of New Chemical Entities (NCEs), including small molecules and peptides. With decades of experience in Big Pharma and Biotech, he has successfully set up, led, and managed pharmaceutical R&D projects from inception to clinical translation. His expertise covers medicinal chemistry, CMC (Chemistry, Manufacturing & Controls) oversight, IP strategy, and due diligence. Dieter works closely with early-stage companies to navigate the complexities of drug development and ensure a smooth transition from research to clinical application.

Dieter can help you with:

• Developing a new chemical entity (NCE) from your discovery or licensing very much depends on choosing the right compound /asset – so ideally let’s link up early.
• ADME (Administration, Distribution, Metabolism, Excretion) advice: What to do and at which stage of your project.
• Defining the most appropriate critical path forward and planning supply throughout research, preclinical development and clinical development.

Milind Raje, Director
MMR Tech Pty Ltd

Milind Raje is an experienced innovation leader with over 20 years in medical device development and manufacturing, having held senior roles at Cochlear, ResMed, and most recently as Manufacturing Director at Onera Health, a startup in the Netherlands. He brings deep expertise across R&D, new product introduction, manufacturing technology, and supply chain development.

Milind has led advanced innovation programs at Cochlear across cochlear implants, bone conduction systems, and sound processors, and contributed to product design and project management at ResMed. He now consults for companies in Europe developing active implants and holds patents across 22 global patent families.

Milind can help you with:

• Product realisation guidance from concept to commercialisation
• Strategic planning, roadmap development, and staged execution within funding constraints
• Guidance for startups on key decision-making and risk management
• Solving complex technology and supply chain challenges
• Partner selection, negotiations, and agreements

Fei Teng, Chief Technology Officer (CTO)
MediRecords

Fei is an accomplished technology executive with twenty years of experience in software development and ten years in strategic leadership. As the CTO of MediRecords, he has a deep understanding of the Australian healthcare technology ecosystem, including Medicare, My Health Record, eRx, secure messaging integration. His expertise also extends to cyber security and healthcare system interoperability standards, including FHIR and HL7. Fei has a proven track record of delivering large-scale digital health projects for clients such as the Department of Defence, Telstra Health, Queensland Health, Northern Health, Macquarie Health, and Medibank.

He can help you with:

• Advising on the overall technology strategy, solution architecture, and technology stack to build a scalable and compliant product, from initial MVP to long-term growth.
• Guidance on technical governance, with a focus on cyber security and the responsible implementation of AI.
• Providing deep insights on integrating with critical Australian infrastructure and standards, including My Health Record (MHR), Medicare, HL7, and FHIR.
• Offering insights on delivering large-scale, complex digital health projects, drawing from direct experience with initiatives valued up to $300 million.
• Assisting founders in preparing for tenders (RFIs, RFPs, and RFQs) and grant applications.

Sue Lynch, Director
Humonics

Sue is a MedTech product development and human factors specialist with a clinical background and over 25 years of experience in the medical device industry. Sue has contributed to the development of over 50 products, including software as a medical device (SaMD) and category-defining digital health solutions.

She combines deep clinical insight from her early career as an ICU nurse with expertise in usability engineering, risk management, and product development to shape technologies that are feasible, desirable, and viable and that clinicians trust and patients adopt.

She can support you with:

• User research and user needs
• Risk management and ISO 14971 and ISO 13485 compliance
• Human factors strategy and compliance with IEC 62366-1 and FDA guidance
• Usability assessment, protocols, testing, and reports
• Understanding design control and the product development process

Dr Mark Flynn
Principal, Global Edge Medtech Consulting

With a global mindset from living and working in Denmark, Sweden, UK, Italy, Argentina, Brazil, Chile, Colombia, Panama, USA, New Zealand, & China, Mark works tirelessly alongside entrepreneurs and clinical innovators to enable global market entry for medical products and services that have a clear patient centric value proposition. With experience in end-to-end translation, commercialisation, and product development, Mark can help your start-up in clearly defining the unmet market need, understanding the clinical context, building a clinical and regulatory strategy, and determining the best reimbursement pathway.

Mark can provide advice on:

• How to fast track your company to the next inflection point
• Developing clinical trial strategy and execution
• Commercialisation experience from launching over 20 medical products and services into global markets
• Determining patient centricity, value proposition and customer needs for your product

Kea Dent, Director
KD&A Regulatory Consultants for Medical and IVD Devices

With over three decades of experience in the medical device sector, Kea possess a wealth of expertise, having worked as both a medical device manufacturer and regulatory consultant and QMS specialist for medical devices and IVDs. Kea can offer medical device regulatory solutions for manufacturers, sponsors, legal representatives, and distributors around the world.

She can help you with your medical device projects by providing:

• Regulatory Strategy (TGA)
• Product Certifications (TGA and global regulatory product)
• Technical Files and Quality Management System (QMS) ( ISO 13485/MDSAP)
• QMS implementation, certification, maintenance, and regulator audits

Hasan Zarin Mehr, CEO
Documedex

Hasan brings over 20 years of global MedTech experience, having supported more than 100 medical device companies, from early-stage start-ups to multinational manufacturers, through regulatory, quality, and commercialisation pathways.

He has held senior leadership roles as a QA/RA Director and served as a Lead Auditor and Medical Device Assessor with EU Notified Bodies, overseeing the conformity assessment of more than 500 medical devices across all risk classes. As CEO of Documedex, he now provides end-to-end Regulatory Compliance (QA/RA) support to MedTech innovators.

Hasan and his team at Documedex can help you with:

• Regulatory strategy & Global market access across Australia (TGA), US (FDA), EU (MDR/CE) and more.
• Technical & Clinical documentation for global submissions, including preclinical studies, biological evaluation, software validation, usability study, risk management, Clinical Evaluation and clinical trial planning & reporting.
• Quality Management Systems implementation (ISO 13485, EU MDR, MDSAP).
• “QA/RA as a Service”: ongoing management of regulatory and quality functions.
• Grant applications, commercialisation planning, and market readiness.

Denis Dmitrenko, Director
MedSec Testing 

MedSec Testing specialises in cybersecurity testing for Medical Devices. Denis has over 20 years of experience in delivering Cybersecurity, Software Development and Testing services across industries such as MedTech, Government and Finance. He leads a team of cybersecurity experts, software engineers, and testers dedicated to developing secure code and ensuring the quality and security of their solutions.

Denis can provide consultation for early developers on topics including, but not limited to:

• Cybersecurity Strategy and Framework
• Cybersecurity Regulatory Requirements for Medical Devices
• Secure Code Practices
• IEC 62304 Software Development
• AI Platforms, Data Modeling and Analytics

Nicolette Muller, Principal Consultant
QA/RA Dynamics 

Nicolette is a seasoned Quality and Regulatory expert with a proven track record of guiding both multinational corporations and startups in the development of medical devices and pharmaceutical products. She has successfully implemented ISO 13485 and 21 CFR 820-compliant Quality Management Systems, identified optimal manufacturing solutions, and facilitated product registrations with regulatory bodies such as the TGA (Australia), FDA (United States), and European Notified Bodies for CE marking.

Nicolette can help you with:

• QMS creation, certification, audits
• Regulatory strategies
• Product registrations FDA, CE Mark , TGA
• Development – Risk management, Verification and Validation testing, Usability Engineering

Paul L Clarke, Director 
Eleven Borders Pty Ltd  

Paul L. Clark brings over 30 years of experience in the international medical device (MedDev) industry, spanning roles in regulatory affairs, quality management, clinical research, operations, and country management. He has worked with regulatory agencies across Australia, Canada, the US, and Europe, and held senior management positions in start-up and medium-sized MedDev companies. Paul’s unique skill set combines regulatory, quality, and clinical expertise with proven commercial experience. His background covers a wide range of MedDev technologies, including renal, cardiovascular, ophthalmic, drug delivery, gastrointestinal, intensive care, wound care, active implantables, and monitoring devices. In his current role, Paul consults and advises MedDev clients while actively participating in the TGA advisory group for AI/SaMD medical device regulation.

Paul can help you with:

• Global Regulatory strategies
• Implementation of ISO 13485 / 21 CFR 820 QMS /MDSAP
• FDA Pre-submission, 510k, De Novo and PMA applications.
• TGA/CE/Health Canada Conformity assessment
• Clinical strategies and clinical evaluation

Lukas Spoegler, Regulatory Affairs Expert for Medical Devices
Johner Institute New Zealand

With extensive experience across Germany and Australia, Lukas has managed international registrations and developed regulatory strategies across major markets, ensuring compliance and market access for every variety of medical devices, including Software as a Medical Device (SaMD), providing coverage across all related areas including technical documentation, and Quality Management Systems (QMS).

The Johner Institute New Zealand consists of a global team of experts, they can help you with:

• Regulatory strategy development for global markets (e.g. Australia, Europe, US) including Regulatory Due Diligence
• Quality Management Systems (ISO 13485)
• Technical Documentation
• Market access and approval pathways for medical devices
• Knowledge transfer to enhance your team's skills through workshops or by providing access to the Medical Device University, an e-learning platform

Hayley Cameron, Medical Device Consultant
SeerPharma 

Hayley has over 18 years of experience in the pharmaceutical and medical device industries with key roles and Management experience across a range of Departments including Production, Quality, Regulatory.

SeerPharma is a team of consultants that provide best-practice advice, training, software solutions and more to pharmaceutical and medical device companies in the Asia-Pacific (APAC) region, assisting companies who are designing and developing new biotechnologies, medical devices and software as a medical device, to help companies take their ideas for new products to market. They can help with:

• Computer Systems Validation
• Quality Management Systems
• Regulatory pathways to market
• Clinical Trial planning

Keren Natalia, Director
SmartQMS 

Keren Natalia is a scientist turned quality leader with over 15 years’ experience helping research labs and biotech companies embed systems that make discoveries reproducible and reliable.
She has guided teams from startups to world-class institutes through ISO and NATA accreditation, working across technologies from IVDs and human tissue biologics to nuclear science, vaccine development, genomics, RNA technology, and most
recently, phage therapy. Her experience spans research institutes (UNSW, Garvan, WIMR, Telethon Kids Institute), startups (Nanosonics, Synthes, Telemedcare, Enterix), and multinationals
(Johnson & Johnson Medical), giving her a uniquely broad perspective on system development.
Keren is passionate about raising awareness on quality and solving reproducibility problems.

• Quality by design for early years
• How to professionalise your start-ups/spinout and show credibility to funders and partners through system implementation
• Exploring ISO requirements and NATA accreditation process
• Best practices and common mistakes for spin-outs and how to avoid them.
• Mapping critical processes and determining control points